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A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer (NeoSCOPE)

Primary Purpose

Oesophageal Cancer

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Oxaliplatin
Capecitabine
Carboplatin
Paclitaxel
Radiotherapy
Surgery
Sponsored by
Lisette Nixon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oesophageal Cancer focused on measuring Oesophageal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed operable oesophageal cancer (adenocarcinoma)
  • Tumour must be staged as a T3, 4 or N1 (using TNM6 staging) or T3, T4a or N13 using TNM7 staging)
  • Maximum disease (Tumour plus nodes) length 8 cm staged with EUS and CT/PET
  • WHO performance status 01
  • Adequate haematological, renal, respiratory, cardiac and hepatic function
  • The patient has provided written informed consent.

Exclusion Criteria:

  • Histologically confirmed operable oesophageal cancer (squamous cell carcinoma)
  • Uncontrolled angina pectoris, myocardial infarction within 6 months, heart failure, clinically significant uncontrolled cardiac arrhythmias, or any patient with a clinically significant abnormal ECG.
  • Patients with any previous treatment for oesophageal carcinoma.
  • Siewert type 3 oesophagogastric tumours.
  • T4 tumours invading contiguous structures other than diaphragm, crura or mediastinal pleura.

  • Patients with disease in any of the following areas on the CT scan, EUS or other staging investigation:

    1. Evidence of metastases in liver, lung, bone or other distant metastases.
    2. Abdominal para aortic lymphadenopathy >1cm diameter on CT or >6mm diameter on EUS.
    3. Invasion of tracheo-bronchial tree, aorta, pericardium or lung.
  • Lymphadenopathy encasing the coeliac axis (as described above, patients with single nodes lying anterior to the origin of the splenic artery and anterior to the origin of the coeliac axis are not excluded).
  • Any patient with a single significant medical condition which is thought likely to compromise his or her ability to tolerate any of the above therapies.
  • Specific contraindications to surgery, chemotherapeutic agents (including known allergies to chemotherapy) or radiotherapy.
  • Pregnant or lactating women and fertile women who will not be using adequate contraception during the trial.

Sites / Locations

  • Bristol Oncology and Haematology CentreRecruiting
  • Valindre NHSRecruiting
  • University Hospitals Coventry and WarwickshireRecruiting
  • Royal Derby Hospital
  • St James's HospitalRecruiting
  • Leicester Royal InfirmaryRecruiting
  • St Mary's HopsitalRecruiting
  • The ChristieRecruiting
  • Churchill HospitalRecruiting
  • Weston Park HospitalRecruiting
  • Southampton General HospitalRecruiting
  • The Great Western HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Carboplatin and Paclitaxel Arm

Oxaliplatin and Capecitabine Arm

Arm Description

2 cycles OxCap: Oxaliplatin 130mg/m2 Day 1 (IV infusion) Capecitabine 625mg/m2 bd Day 1- 21 (oral) then CRT: Paclitaxel 50mg/m2 Days 1,8,15,22,29 (IV infusion); Carboplatin AUC 2 Days 1,8,15,22,29 (IV infusion) XRT: 45 Gy in 25 fractions then surgery. All drugs will be sourced from local stock

2 cycles OxCap: Oxaliplatin 130mg/m2 Day 1 (IV infusion) Capecitabine 625mg/m2 bd Day 1- 21 (oral) then CRT: Oxaliplatin 85mg/m2 Days 1, 15, 29 (IV infusion); Capecitabine 625mg/m2 bd (oral) only on days when receiving RT XRT: 45 Gy in 25 fractions* then surgery. All drugs will be sourced from local stock

Outcomes

Primary Outcome Measures

Efficacy
The efficacy of the trial treatment will be assessed by conducting analysis on the resected tumour specimen of participants undergoing surgery. This will be achieved by looking at the pathological complete response rate (pCR).

Secondary Outcome Measures

Feasibility of recruiting 62 patients within 18 months
Feasibility of recruiting to a pre-operative chemoradiotherapy trial in the UK will be determined by recruitment within 18 months.
Safety
The trial safety will be assessed by looking at the toxicity. Toxicities during treatment and at 6 and 12 months post-surgery will be recorded using the CTCAE version 4. SAEs will be collected in real time. The morbidity/mortality rate post surgery will also be assessed.
Efficacy
The efficacy will be measured as a secondary end point by assessing the median, 3 and 5 year overall survival.
Efficacy
The CRM (circumferential resection margin) which is a measurement of how successful the surgery was in removing all traces of tumour, will be assessed.

Full Information

First Posted
March 7, 2013
Last Updated
March 21, 2014
Sponsor
Lisette Nixon
Collaborators
Cancer Research UK
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1. Study Identification

Unique Protocol Identification Number
NCT01843829
Brief Title
A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer
Acronym
NeoSCOPE
Official Title
A Randomised Phase II Study of Two Pre-operative Chemoradiotherapy Regimens (Oxaliplatin and Capecitabine Followed by Radiotherapy With Either Oxaliplatin and Capecitabine or Paclitaxel and Carboplatin) for Resectable Oesophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lisette Nixon
Collaborators
Cancer Research UK

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
About 7500 patients are diagnosed with oesophageal cancer each year in the UK of which less than a quarter have resectable disease at diagnosis. There is a general lack of consistency in the standard of care for patients across UK hospitals. Patients are either treated with a) chemotherapy followed by surgical removal of the tumour, or b) chemoradiotherapy followed by removal of the tumour by surgery, as part of their standard of care. Recent research supports the latter treatment, as chemoradiotherapy maybe more effective at shrinking the tumour and preventing the disease from spreading than taking chemotherapy alone. However, there is no definitive way of identifying which treatment is best without a clinical trial. Evidence suggests that the effect of the chemoradiotherapy currently used as standard practice may be improved and the side effects reduced by using a different chemoradiotherapy combination. In this trial, eligible patients will receive 2 cycles of the same chemotherapy before being randomised to receive two different chemoradiotherapy regimens (carboplatin and paclitaxel verses oxaliplatin and capecitabine) both of which have shown promising results in previous studies. Patients will then have their tumour removed. The best chemoradiotherapy regimen will then be taken forward to a Phase III trial in which chemoradiotherapy will be compared with chemotherapy alone. The efficacy of the regimens will be measured by counting the number of patients who i) remain free from cancer, ii)have local or distant spread of their cancer, iii) are successfully recruited and iv) experience toxicities. A specific set of toxicity criteria will be used to monitor any treatment induced side-effects and provide justification for any necessary dose modifications or withdrawal of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oesophageal Cancer
Keywords
Oesophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carboplatin and Paclitaxel Arm
Arm Type
Experimental
Arm Description
2 cycles OxCap: Oxaliplatin 130mg/m2 Day 1 (IV infusion) Capecitabine 625mg/m2 bd Day 1- 21 (oral) then CRT: Paclitaxel 50mg/m2 Days 1,8,15,22,29 (IV infusion); Carboplatin AUC 2 Days 1,8,15,22,29 (IV infusion) XRT: 45 Gy in 25 fractions then surgery. All drugs will be sourced from local stock
Arm Title
Oxaliplatin and Capecitabine Arm
Arm Type
Experimental
Arm Description
2 cycles OxCap: Oxaliplatin 130mg/m2 Day 1 (IV infusion) Capecitabine 625mg/m2 bd Day 1- 21 (oral) then CRT: Oxaliplatin 85mg/m2 Days 1, 15, 29 (IV infusion); Capecitabine 625mg/m2 bd (oral) only on days when receiving RT XRT: 45 Gy in 25 fractions* then surgery. All drugs will be sourced from local stock
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Patients will have their tumour surgically removed by two-phase oesophagectomy and two-field lymphadenectomy.
Primary Outcome Measure Information:
Title
Efficacy
Description
The efficacy of the trial treatment will be assessed by conducting analysis on the resected tumour specimen of participants undergoing surgery. This will be achieved by looking at the pathological complete response rate (pCR).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Feasibility of recruiting 62 patients within 18 months
Description
Feasibility of recruiting to a pre-operative chemoradiotherapy trial in the UK will be determined by recruitment within 18 months.
Time Frame
18 months
Title
Safety
Description
The trial safety will be assessed by looking at the toxicity. Toxicities during treatment and at 6 and 12 months post-surgery will be recorded using the CTCAE version 4. SAEs will be collected in real time. The morbidity/mortality rate post surgery will also be assessed.
Time Frame
3 years
Title
Efficacy
Description
The efficacy will be measured as a secondary end point by assessing the median, 3 and 5 year overall survival.
Time Frame
5 years
Title
Efficacy
Description
The CRM (circumferential resection margin) which is a measurement of how successful the surgery was in removing all traces of tumour, will be assessed.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed operable oesophageal cancer (adenocarcinoma) Tumour must be staged as a T3, 4 or N1 (using TNM6 staging) or T3, T4a or N13 using TNM7 staging) Maximum disease (Tumour plus nodes) length 8 cm staged with EUS and CT/PET WHO performance status 01 Adequate haematological, renal, respiratory, cardiac and hepatic function The patient has provided written informed consent. Exclusion Criteria: Histologically confirmed operable oesophageal cancer (squamous cell carcinoma) Uncontrolled angina pectoris, myocardial infarction within 6 months, heart failure, clinically significant uncontrolled cardiac arrhythmias, or any patient with a clinically significant abnormal ECG. Patients with any previous treatment for oesophageal carcinoma. Siewert type 3 oesophagogastric tumours. T4 tumours invading contiguous structures other than diaphragm, crura or mediastinal pleura. Patients with disease in any of the following areas on the CT scan, EUS or other staging investigation: Evidence of metastases in liver, lung, bone or other distant metastases. Abdominal para aortic lymphadenopathy >1cm diameter on CT or >6mm diameter on EUS. Invasion of tracheo-bronchial tree, aorta, pericardium or lung. Lymphadenopathy encasing the coeliac axis (as described above, patients with single nodes lying anterior to the origin of the splenic artery and anterior to the origin of the coeliac axis are not excluded). Any patient with a single significant medical condition which is thought likely to compromise his or her ability to tolerate any of the above therapies. Specific contraindications to surgery, chemotherapeutic agents (including known allergies to chemotherapy) or radiotherapy. Pregnant or lactating women and fertile women who will not be using adequate contraception during the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisette Nixon
Phone
02920687458
Email
nixonls@cardiff.ac.uk
Facility Information:
Facility Name
Bristol Oncology and Haematology Centre
City
Bristol
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Valindre NHS
City
Cardiff
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Crosby
Facility Name
University Hospitals Coventry and Warwickshire
City
Coventry
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Derby Hospital
City
Derby
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajendra Kulkarni
Facility Name
St James's Hospital
City
Leeds
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ganesh Radhakrishna
Facility Name
Leicester Royal Infirmary
City
Leicester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
St Mary's Hopsital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Christie
City
Manchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamid Sheikh
Facility Name
Churchill Hospital
City
Oxford
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Weston Park Hospital
City
Sheffield
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Southampton General Hospital
City
Southampton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Great Western Hospital
City
Swindon
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
34157617
Citation
Mukherjee S, Hurt C, Radhakrishna G, Gwynne S, Bateman A, Gollins S, Hawkins MA, Canham J, Grabsch HI, Falk S, Sharma RA, Ray R, Roy R, Cox C, Maynard N, Nixon L, Sebag-Montefiore DJ, Maughan T, Griffiths GO, Crosby TDL. Oxaliplatin/capecitabine or carboplatin/paclitaxel-based preoperative chemoradiation for resectable oesophageal adenocarcinoma (NeoSCOPE): Long-term results of a randomised controlled trial. Eur J Cancer. 2021 Aug;153:153-161. doi: 10.1016/j.ejca.2021.05.020. Epub 2021 Jun 20.
Results Reference
derived
PubMed Identifier
28335886
Citation
Mukherjee S, Hurt CN, Gwynne S, Sebag-Montefiore D, Radhakrishna G, Gollins S, Hawkins M, Grabsch HI, Jones G, Falk S, Sharma R, Bateman A, Roy R, Ray R, Canham J, Griffiths G, Maughan T, Crosby T. NEOSCOPE: A randomised phase II study of induction chemotherapy followed by oxaliplatin/capecitabine or carboplatin/paclitaxel based pre-operative chemoradiation for resectable oesophageal adenocarcinoma. Eur J Cancer. 2017 Mar;74:38-46. doi: 10.1016/j.ejca.2016.11.031. Epub 2017 Feb 8.
Results Reference
derived
PubMed Identifier
25880814
Citation
Mukherjee S, Hurt CN, Gwynne S, Bateman A, Gollins S, Radhakrishna G, Hawkins M, Canham J, Lewis W, Grabsch HI, Sharma RA, Wade W, Maggs R, Tranter B, Roberts A, Sebag-Montefiore D, Maughan T, Griffiths G, Crosby T. NEOSCOPE: a randomised Phase II study of induction chemotherapy followed by either oxaliplatin/capecitabine or paclitaxel/carboplatin based chemoradiation as pre-operative regimen for resectable oesophageal adenocarcinoma. BMC Cancer. 2015 Feb 12;15:48. doi: 10.1186/s12885-015-1062-y.
Results Reference
derived

Learn more about this trial

A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer

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